Back in October, Rally started a project led by Craig Lagenfeld, one or our great Technical Account Managers, and Dean Leffingwell, see more on Dean below, to take the FUD (Fear, Uncertainty and Doubt) out of this application of agile methods.
If we hit this out of the park, we will be delivering guidance to the Agile Community that describes the best practice for developing high assurance software in highly regulated environments. The primary guidance will be a detailed “how to” whitepaper that will include examples of organizations who are already utilizing one or more of the practices and tools that we describe. Other deliverables will include a blog series, webinar, and tool validation guide. In short, the Agile Community will change their question from “can we utilize Agile to create high assurance software and still be compliant” to “how soon can we get the process and tools implemented to take advantage of Agile”.
Now two months into the project, we are trying to broaden the audience and collaborators for this work. We’re excited about this project and the great feedback we are getting from the Agile community. The blog series is generating a lot of interest, with people either wanting to know more or offering to contribute. Heck we even have quite a few emails from the Compliance Community wanting to help us out. Keep the emails coming- or better yet, start directing all of your support, questions, and feedback to the blog posts (and comments on this post) so that we can keep this building in a public forum. In the end Dean and I plan to deliver much more than a series of blog posts. We want to deliver guidance that Rally customers and Agile Practitioners can use to educate themselves and their organization.
The purpose of the project is to bring together Agilists who know that Agile is a better way to produce safe, reliable innovations but are unsure of how to accomplish this within a highly regulated environment. In our second post, Dean and I decided to use medical devices as the focus of our work, providing real examples of how medical device companies are confidentially using Agile practices today (see our recent posts on Abbott Labsand GE Healthcare). My part in the project focuses largely on ensuring that we provide a best of breed tooling suggestion to support the process that Dean and other experts in the field are developing. – Craig Langenfeld
Dean Leffingwell is a great friend, author, and entrepreneur. Before starting Requisite, the orignal makers of Req Pro, Dean ran a company called Rella that manufactured medical devices. Not only does he know software, agility and lean, but has many stripes from medical device certification and compliance. We are thrilled to be collaborating with him again; if you do not know his work, he is the author of Scaling Software Agility: Best Practices for Large Enterprises and the soon to be published Agile Software Requirements: Lean Requirements Practices for Teams, Programs and the Enterprise.
Again, if you are in this field please join Criag, Dean and your peers in the High Assurance and Regulated category of Dean’s blog.
Craig Lagenfeld is a Technical Account Manager at Rally Software Development.
Dean Leffingwell is an entrepreneur, executive, author and consulting methodologist.